Dive Brief:
- Emergent BioSolutions will produce a quadrivalent flu vaccine developed by Novavax, which recently announced positive late-stage study results for the experimental treatment.
- Emergent, which develops its own drugs and contracts with other companies, plans to make the NanoFlu vaccine at its Baltimore Bayview location. The facility is also working on an experimental Novavax vaccine for the new coronavirus, which causes the disease COVID-19.
- Emergent will have the flexibility to ramp up coronavirus-related work at Bayview if the vaccine candidate shows promise, the company said in a March 31 release.
Dive Insight:
For Novavax, the manufacturing deal should help it clear another hurdle in its bid to break into a market dominated by giants such as Sanofi, Pfizer and GlaxoSmithKline. Emergent's facility, designated by the U.S. government as a Center for Innovation in Advanced Development and Manufacturing, can produce hundreds of millions of doses of vaccine each year, the company said.
The agreement is a key step toward filing for Food and Drug Administration approval of the vaccine, Cantor Fitzgerald analysts Charles Duncan and Pete Stavropoulos wrote in a note to investors. That will probably occur in 2021 or earlier, they said.
Novavax's study found that significantly more patients on NanoFlu developed flu-fighting antibodies than those on Sanofi's Fluzone. The positive results bode well not only for potential approval of NanoFlu, but also for the overall technology that Novavax uses, Duncan and Stavropoulos wrote.
For Emergent, meanwhile, the deal with Novavax may be a "meaningful contributor to growth," Cantor Fitzgerald analyst Brandon Folkes wrote in a separate note to investors. It will help Emergent as it tries to reach a goal of $2 billion in company revenue by 2024, Folkes said.
While the flu vaccine is much further along, Novavax's coronavirus candidate is also drawing interest as the COVID-19 pandemic intensifies in the U.S.
There have now been more than 980,000 COVID-19 cases recorded around the world, with more than 50,000 deaths, according to data from Johns Hopkins University. The U.S. now has more cases than any other country.
The flu vaccine study showing "very good safety data" may be helpful in the coronavirus work, Novavax CEO Stanley Erck told investors on March 24. Both the coronavirus candidate vaccine and NanoFlu would be made with Novavax's nanoparticle technology platform and used in many of the same types of patients.